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Memorandum .  FXB 25
Memorandum . FXB 25

... the Slovak Republic, Belarus, and the Ukraine. Registration for sale is pending in Canada and the Yeman Republic. The Humifulvate that is the subject of this notification is the same substance that has been tested, analyzed, and approved as a component of HumetB-R (see Attachment 2) and will be manu ...
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Equianalgesic Dosing of Opioids for Pain Management

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Maropitant: Novel Antiemetic

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Roadmap of stability studies on Biosimilar product development

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High Performance Liquid Chromatography for Clinical Applications

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ISSN 1608-2281 2006 6(3):179-181
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... ones are not? Of the useful compounds, which ones will be of interest to the companies that manufacture drugs and which ones will not? These issues are exceptionally complex, and become even more so, when the health issue is something other than an invading organism. In considering chronic pain mana ...
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... Current Pharmacy functionality is not patient centric and does not include adequate decision support capabilities required for a modern healthcare system. Approximately 124 requests for system improvement have been referred to Pharmacy Reengineering and are deemed not feasible to be implemented in L ...
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Pharmacokinetics in pregnancy

... schedule will depend on the size of the e€ect for individual drugs and also how critically therapeutic ecacy/toxicity relates to plasma concentrations. For drugs with a low therapeutic index (the ratio of a therapeutic to a toxic dose) these e€ects may be much more important. Unfortunately, speci®c ...
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Adulteration and Evaluation of Crude drugs

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DRY SYRUPS

... formulation will not stand up to the physical and chemical stresses of granulation . Powders or granules for reconstitution may be ...
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Rethinking and Restructuring the FDA Drug Approval Process in

... mandate, critics contend that the FDA cannot rely on private drug manufacturers to selfregulate their products. Merck’s decision is a mere indicator of the substantial problems that cripple the effectiveness of FDA pharmaceutical regulatory approvals, particularly in regard to the management and use ...
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Biosimilar

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is a copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original ""innovator"" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product.Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; animal studies (including the assessment of toxicity); and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted in order to demonstrate their highly similar properties. Consequently, EMA have granted a marketing authorisation for only a few numbers of biosimilars since 2006 including a monoclonal antibody which is recently approved. Meanwhile, on March 6, 2015, the FDA approved the United States's first biosimilar product, the biosimilar filgrastim Zarxio.
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